CTIS2023-504805-35-00招募中1 期
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma - GCT3013-02
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Genmab A/S
- 入组人数
- 555
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Subject must sign an ICF, At least 18 years of age, Measurable disease defined as =1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or =1 measurable extra-nodal lesion (long axis >1.0 cm) on CT or MRI, ECOG PS score of 0, 1 or 2, Acceptable organ function at screening, CD20-positive NHL at most recent representative tumor biopsy, If of childbearing potential subject must practicing a highly effective method of birth control, A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control, Life expectancy >2 months with SOC treatment. Arm 1: One of these confirmed histologies: - DLBCL, NOS - T-cell/histiocyte rich DLBCL - double-hit or triple-hit DLBCL - FL Grade 3B Arm 2 and Arm 9: R/R FL Arm 3: Newly diagnosed, previously untreated FL grade 1-3A Arm 4 and Arm 10: One of these confirmed histologies and eligible for HDT-ASCT - DLBCL, NOS - T-cell/histiocyte rich DLBCL - double-hit or triple-hit DLBCL - FL Grade 3B Arm 5: One of these confirmed histologies and ineligible for HDT-ASCT - DLBCL, NOS - T-cell/histiocyte rich DLBCL - double-hit or triple-hit DLBCL - FL Grade 3B Arm 6: previously untreated CD20+ FL Arm 7: FL and in CR or PR per Lugano criteria following first-line or second-line treatment with SOC regiment at last treatment received, and last dose of SOC within 6 months prior to enrollment Arm 8: One of these confirmed histologies: - DLBCL, NOS - T-cell/histiocyte rich DLBCL - double-hit or triple-hit DLBCL -FL Grade 3B For Arm8, subjects must be ineligible to receive full-dose anthracycline (as part of R-CHOP) per eligibility criteria Arm 9: Must have received only 1 prior line of therapy. This first-line therapy must have included an anti-CD20 antibody in combination with chemotherapy. Progressed within 24 months of initiating first-line treatment
排除标准
- •Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab, Subject has current seizure disorder requiring anti-epileptic therapy, Any prior treatment with a bispecific antibody targeting CD3 and CD20., Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab, Clinically significant cardiovascular disease, Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, Primary CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture, Active HBV or HCV (DNA PCR positive infection), Known history of seropositivity for human immunodeficiency virus (HIV), Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
研究者
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